MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 8X30; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CR0830
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization procedure, the physician tried to place one coil, an 8mm x 30cm orbit galaxy complex frame (640cr0830 / 30606917) and the tip would not sit within the hub of the microcatheter (unspecified brand).Another coil, a 7mm x 25cm orbit galaxy complex frame (640cr0725 / 30848871) was placed into the target aneurysm but at the last few cm, the coil became hard to advance and the pusher wire broke during the attempt to advance.It was reported that flush lines were maintained through the microcatheter.There was no report of any adverse event or negative patient impact.On 19-apr-2023, additional information was received.The information indicated that (b)(6) was treating a left internal carotid artery (ica) fistula.The fistula was irregular, measuring 10mm x 18mm.The headway® duo.0165 microcatheter (microvention) was used for the entire procedure.The information indicated that the pusher wire broke in two pieces.The wire was still exposed out of the rotating hemostasis valve (rhv) that was connected to the microcatheter and was removed easily.There were not visible kinks observed on the microcatheter.There was no resistance friction during the insertion of the 7mm x 25cm orbit galaxy complex frame coil.There was no damage on the coil component of the 7mm x 25cm orbit galaxy complex frame coil when it was removed; the embolic coil was still intact / attached to the delivery system.After the coil was removed, additional coils were opened and placed with no issues.They had another 7mm x 25cm orbit galaxy complex frame coil that was placed.The information confirmed that there was no negative patient impact, no patient issues.There was no procedure delay as a result of the reported issue.The complaint devices were returned and received on 10-may-2023.Based on the result of the product analysis completed on 16-jun-2023, the reported issue associated with this device has been determined to be us fda reportable as a ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d2b: procode is krd/hcg.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 8mm x 30cm orbit galaxy complex frame was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the support coil was protruded from the introducer.The introducer was inspected and found to be in good, normal condition (i.E., no elongations, no kinks, and no bends).The inner diameter (id) and outer diameter (od) of the introducer were confirmed to be within specifications.The embolic coil component was inspected under the microscope.Under magnification, some loops near the distal tip were observed to be kinked.The complaint device was connected to an rhv (rotating hemostasis valve) to a lab sample syringe and to a lab sample microcatheter.The system was flushed with water colored with food coloring and the introducer was noted to be properly engaged with the luer hub of the microcatheter.No anomalies were observed.A review of manufacturing documentation associated with this lot (30606917) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.The issue regarding the tip not sitting within the hub of the microcatheter was not confirmed, since no issues were detected during the analysis of the device, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.The kinked condition found on the distal end of the coil was not originally reported, and it is suspected to be a result of the attempts to position the introducer into the hub of the microcatheter, however, it is not related to the inability to sit the introducer tip within the hub as reported.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following instruction: gently insert the introducer tip into the rhv until it can go no further and is in close alignment with the hub of the infusion microcatheter.Gently tighten the rhv main valve around the introducer sheath to prevent back flow of blood.Visually inspect the alignment of the introducer tip and the microcatheter hub to ensure they have not slipped apart.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00252.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG TDL CMPLX FRAME COIL 8X30
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 17146750
• Report Number: 3008114965-2023-00401
• Device Sequence Number: 5577681
• Product Code: KRD
• UDI-Device Identifier: 10886704030454
• UDI-Public: 10886704030454
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 640CR0830
• Device Catalogue Number: 640CR0830
• Device Lot Number: 30606917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY® DUO .0165 MICROCATHETER (MICROVENTION)
• Patient Sex: Unknown